But you do realize there is 0 clinical research on Aegeline in humans whatsoever?

You also realize that Aegle Marmelos is indicated as a human health risk by the European Food Safety Agency right?

You further realize that some USPLabs shill account edited in a blurb to wikipedia claiming Aegeline has a history of being used as a supplement, referencing 4 studies that in no way indicate it has a history of being used as a supplement in the US. And deleted the hazards section of the article.

Also, USPLabs didn't submit an NDI for Aegeline, when Aegeline itself has NOT been sold on its own as a dietary supplement before the DSHEA's passing, as Aegline wasn't even an identified constituent of Aegle Marmelos before the DSHEA, nor has it received GRAS status.

Am I saying it's dangerous? Who knows, there's no data to show that it's not, and the ESFA thinks it potentially is.

Am I saying it's ineffective? Not really, high tower pharmacology and Patrick Arnold and No HYPE make a clear argument that it is not.

Furthermore, the only scientific reference they make that alludes to an anabolic effect references a difference alkylamide substance from a different plant entirely, containing a differently behaving compound, and all claims made specifically to the effectiveness of Aegeline appear to be ghosts from USPLabs 'internal data'.

But hey, you go on and throw your money away.

Oh right, and more related to this thread, what possible effect of Aegeline can be claimed that is in any way conducive to a PCT-specific situation?

But you do realize there is 0 clinical research on Aegeline in humans whatsoever?

You also realize that Aegle Marmelos is indicated as a human health risk by the European Food Safety Agency right?

You further realize that some USPLabs shill account edited in a blurb to wikipedia claiming Aegeline has a history of being used as a supplement, referencing 4 studies that in no way indicate it has a history of being used as a supplement in the US. And deleted the hazards section of the article.

Also, USPLabs didn't submit an NDI for Aegeline, when Aegeline itself has NOT been sold on its own as a dietary supplement before the DSHEA's passing, as Aegline wasn't even an identified constituent of Aegle Marmelos before the DSHEA, nor has it received GRAS status.

Am I saying it's dangerous? Who knows, there's no data to show that it's not, and the ESFA thinks it potentially is.

Am I saying it's ineffective? Not really, high tower pharmacology and Patrick Arnold and No HYPE make a clear argument that it is not.

Furthermore, the only scientific reference they make that alludes to an anabolic effect references a difference alkylamide substance from a different plant entirely, containing a differently behaving compound, and all claims made specifically to the effectiveness of Aegeline appear to be ghosts from USPLabs 'internal data'.

But hey, you go on and throw your money away.

Oh right, and more related to this thread, what possible effect of Aegeline can be claimed that is in any way conducive to a PCT-specific situation?

I didn't say there was clinical research.

I also don't care if the EFSA doesn't allow it, considering there is nothing to show it's dangerous.

My point is the logs show it to be effective and you are claiming an effective product will be discontinued when you haven't used it to gauge its effectiveness.

But you do realize there is 0 clinical research on Aegeline in humans whatsoever?

You also realize that Aegle Marmelos is indicated as a human health risk by the European Food Safety Agency right?

You further realize that some USPLabs shill account edited in a blurb to wikipedia claiming Aegeline has a history of being used as a supplement, referencing 4 studies that in no way indicate it has a history of being used as a supplement in the US. And deleted the hazards section of the article.

Also, USPLabs didn't submit an NDI for Aegeline, when Aegeline itself has NOT been sold on its own as a dietary supplement before the DSHEA's passing, as Aegline wasn't even an identified constituent of Aegle Marmelos before the DSHEA, nor has it received GRAS status.

Am I saying it's dangerous? Who knows, there's no data to show that it's not, and the ESFA thinks it potentially is.

Am I saying it's ineffective? Not really, high tower pharmacology and Patrick Arnold and No HYPE make a clear argument that it is not.

Furthermore, the only scientific reference they make that alludes to an anabolic effect references a difference alkylamide substance from a different plant entirely, containing a differently behaving compound, and all claims made specifically to the effectiveness of Aegeline appear to be ghosts from USPLabs 'internal data'.

But hey, you go on and throw your money away.

Oh right, and more related to this thread, what possible effect of Aegeline can be claimed that is in any way conducive to a PCT-specific situation?

Took a look at the FDA register and emailed them, its a fact that you didn't submit an NDI for aegeline, after being warned in your jack3d warning letter about your general practices with regards to NDIs on ingredient specific plant extracts. (Not to mention, if this aegeline is synthetic and not an extract, the FDA position is that it is by definition not DSHEA compliant.)

I say it is my opinion that it will probably be discontinued within a year or two because if you just discontinue a product before the FDA ever gets around to investigating you, you can generally avoid trouble as long as you weren't selling steroids.

But you do realize there is 0 clinical research on Aegeline in humans whatsoever?

You also realize that Aegle Marmelos is indicated as a human health risk by the European Food Safety Agency right?

You further realize that some USPLabs shill account edited in a blurb to wikipedia claiming Aegeline has a history of being used as a supplement, referencing 4 studies that in no way indicate it has a history of being used as a supplement in the US. And deleted the hazards section of the article.

Also, USPLabs didn't submit an NDI for Aegeline, when Aegeline itself has NOT been sold on its own as a dietary supplement before the DSHEA's passing, as Aegline wasn't even an identified constituent of Aegle Marmelos before the DSHEA, nor has it received GRAS status.

Am I saying it's dangerous? Who knows, there's no data to show that it's not, and the ESFA thinks it potentially is.

Am I saying it's ineffective? Not really, high tower pharmacology and Patrick Arnold and No HYPE make a clear argument that it is not.

Furthermore, the only scientific reference they make that alludes to an anabolic effect references a difference alkylamide substance from a different plant entirely, containing a differently behaving compound, and all claims made specifically to the effectiveness of Aegeline appear to be ghosts from USPLabs 'internal data'.

But hey, you go on and throw your money away.

Oh right, and more related to this thread, what possible effect of Aegeline can be claimed that is in any way conducive to a PCT-specific situation?

But you do realize there is 0 clinical research on Aegeline in humans whatsoever?

You also realize that Aegle Marmelos is indicated as a human health risk by the European Food Safety Agency right?

You further realize that some USPLabs shill account edited in a blurb to wikipedia claiming Aegeline has a history of being used as a supplement, referencing 4 studies that in no way indicate it has a history of being used as a supplement in the US. And deleted the hazards section of the article.

Also, USPLabs didn't submit an NDI for Aegeline, when Aegeline itself has NOT been sold on its own as a dietary supplement before the DSHEA's passing, as Aegline wasn't even an identified constituent of Aegle Marmelos before the DSHEA, nor has it received GRAS status.

Am I saying it's dangerous? Who knows, there's no data to show that it's not, and the ESFA thinks it potentially is.

Am I saying it's ineffective? Not really, high tower pharmacology and Patrick Arnold and No HYPE make a clear argument that it is not.

Furthermore, the only scientific reference they make that alludes to an anabolic effect references a difference alkylamide substance from a different plant entirely, containing a differently behaving compound, and all claims made specifically to the effectiveness of Aegeline appear to be ghosts from USPLabs 'internal data'.

But hey, you go on and throw your money away.

Oh right, and more related to this thread, what possible effect of Aegeline can be claimed that is in any way conducive to a PCT-specific situation?

Aegeline has been in the food supply prior to 1994 therefore a dietary ingredient.

Took a look at the FDA register and emailed them, its a fact that you didn't submit an NDI for aegeline, after being warned in your jack3d warning letter about your general practices with regards to NDIs on ingredient specific plant extracts. (Not to mention, if this aegeline is synthetic and not an extract, the FDA position is that it is by definition not DSHEA compliant.)

I say it is my opinion that it will probably be discontinued within a year or two because if you just discontinue a product before the FDA ever gets around to investigating you, you can generally avoid trouble as long as you weren't selling steroids.

You've been sent here by hightower to do his work. Do you kneel and pray to him...

Much of the industry is in a constant state of non-compliance with letter of FDA law, and that poses a risk to supplement availability to all of us.

USPLabs just happens to be a company that looks for novel ingredients a lot (which is a good thing, innovation is great!), I just wish they and other companies took it slower, for the long term benefit of the industry, consumer choice, and ultimately their bottom line.

If consumed as food prior to 1994 it qualifies as a dietary ingredient...

Was *Aegeline* consumed as food prior to 1994 in the United States?

Not Bael fruit. Aegeline. Is Aegeline even in the fruit of Bael tree, as that is what is consumed as food and not the leaves/stems?

If you label your product as containing the compound itself and not a concentrated extract you have to demonstrate that the compound on its own was in the food supply.

Also, if your Aegeline is synthetically manufactured, it is by definition of FDA regulations not a dietary ingredient.

It has come to our attention that dimethylamylamine used in products in the dietary supplement marketplace may be produced synthetically. Section 201(ff)(1) of the Act (21 U.S.C. 321(ff)(1)) defines "dietary ingredient" as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. Synthetically produced dimethylamylamine is not a vitamin, mineral, amino acid, herb or other botanical. To the best of FDA’s knowledge, synthetically produced dimethylamylamine is not commonly used as a food or drink; therefore, it is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, synthetically produced dimethylamylamine is not a concentrate, metabolite, constituent, extract or combination of a dietary ingredient. Therefore, synthetically produced dimethylamylamine is not a dietary ingredient as defined in section 201(ff)(1) of the Act.

That's in their letter to you over DMAA, if you substitute DMAA for Aegeline, the exact holds true. So if you're going the synthetic route, you're probably treading very dangerous water with the FDA

I'm saying there seems to be an absence of proof that "Versa-1 works" or that "Versa-1 is safe" or even that "Versa-1 is FDA compliant" and that it would be USPLabs obligation to establish those two facts, both to customers and to the FDA, prior to expecting people to spend money on it.

Whether people want to spend money on it is up to them. I'm just stating my opinion.

That's new draft GUIDANCE dumbass...Do you know the meaning of "draft"....That's new draft GUIDANCE dumbass...Do you know the meaning of "draft"....As a supplement consumer and you seem like a bright ****er, you would understand that if the DRAFT guidance was passed the supplement industry is dead.Are you in favor of that?

My statement was based on current letter of law revisions to the FDCA made by DSHEA. Requirements being that a product meet one of the two following requirements:

The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or

There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

Hence my questions over whether you have found Aegeline in Bael Tree *Fruits*, as that is the only part of the plant that the USDA records as being found in the US food supply, and Aegeline was only found at ~2000 ppm in the *leaves* of Aegle Marmelos. And again, just as with the letter you got over DMAA, the FDA would certainly not consider synthetic Aegeline to fit into the definition of dietary ingredient.

Also, how does citicoline meet ingredient requirements?

It looks like you're going for satisfying requirement one which is where it seems that you fall short if the FDA were to actually take notice and investigate you.

You could probably file an NDI on the ingredient and be totally fine if you elected to go for requirement two and you used safety data citing all of your human testing to show that Aegeline on its own does not show any of the negative effects possible with Aegle Marmelos leaves as a whole.

---

As for the draft guidance for NDIs, the FDA certainly overstretched a lot, but that was probably tactical on their part so they can come out with a more reasonable but still more restrictive than current law notice later this year (the revision is in progress...not sure on an ETA for release). But that's sort of my point in all of this. The FDA doesn't have to convince all of us in the fitness world that what they are doing is best. They just have to be able to show the general public 'hey look at these shady supplement companies putting you in danger, what we're doing is totally justified'

My statement was based on current letter of law revisions to the FDCA made by DSHEA. Requirements being that a product meet one of the two following requirements:

Hence my questions over whether you have found Aegeline in Bael Tree *Fruits*, as that is the only part of the plant that the USDA records as being found in the US food supply, and Aegeline was only found at ~2000 ppm in the *leaves* of Aegle Marmelos. And again, just as with the letter you got over DMAA, the FDA would certainly not consider synthetic Aegeline to fit into the definition of dietary ingredient.

Also, how does citicoline meet ingredient requirements?

It looks like you're going for satisfying requirement one which is where it seems that you fall short if the FDA were to actually take notice and investigate you.

You could probably file an NDI on the ingredient and be totally fine if you elected to go for requirement two and you used safety data citing all of your human testing to show that Aegeline on its own does not show any of the negative effects possible with Aegle Marmelos leaves as a whole.

---

As for the draft guidance for NDIs, the FDA certainly overstretched a lot, but that was probably tactical on their part so they can come out with a more reasonable but still more restrictive than current law notice later this year (the revision is in progress...not sure on an ETA for release). But that's sort of my point in all of this. The FDA doesn't have to convince all of us in the fitness world that what they are doing is best. They just have to be able to show the general public 'hey look at these shady supplement companies putting you in danger, what we're doing is totally justified'

Well you said it...

The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered;